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Hillevax
Boston, MA, United States
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 mil
Job Source: HillevaxMonte Rosa Therapeutics
Boston, MA, United States
Associate Director – Quality Systems Location: Boston, MA Role Summary: Monte Rosa Therapeutics is seeking a passionate Associate Director/Director of Quality Systems is responsible for maintaining and maturing Monte Rosa Tx’s GxP Quality System, which includes, but is not limited to documentation, training, supplier quality, internal audits, prod
Job Source: Monte Rosa TherapeuticsHilleVax, Inc.
Boston, MA, United States
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 mil
Job Source: HilleVax, Inc.Rhythm Pharmaceuticals
Boston, MA, United States
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families.
Job Source: Rhythm PharmaceuticalsFogPharma
Cambridge, MA, United States
Why join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by
Job Source: FogPharmaRhythm Pharmaceuticals, Inc
Boston, MA, United States
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families.
Job Source: Rhythm Pharmaceuticals, IncRhythm Pharmaceuticals
Boston, MA, United States
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families
Job Source: Rhythm PharmaceuticalsHillevax
Boston, MA, United States
Thanks for visiting our Career Page. Please review our open positions and apply to the positions that match your qualifications. Associate Director/Director, Quality Control (Analytical) HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-li
Job Source: HillevaxNatick, MA, United States
Job Type
Full-time
Description
Kula Bio is a leader in sustainable nitrogen solutions, helping farmers improve crop yield and reduce environmental impact. We are producing a cost-competitive biofertilizer that boosts a naturally occurring process to deposit meaningful amounts of nitrogen in the soil. We are seeking a hands- on Analytical Bio/Chemist with experience in Quality Assurance and Quality Control to lead our team as the Associate Director of Quality.
In this role, you will be instrumental in ensuring Kula Bio products meet or exceed company and customer expectations while following regulatory requirements. On a regular day, you will develop, implement, and continuously improve the organization's quality strategy, and policies; install, commission, and validate analytical equipment such as HPLC, GC, chromatography, biochemistry analyzer, carbon/Nitrogen Analyzer; perform routine daily sample analysis; establish and/or maintain a robust Quality Management System (QMS) that complies with relevant industry standards (e.g., ISO 9001); oversee product/service inspections, audits, and testing procedures, and develop metrics to monitor quality performance and drive improvement initiatives, and identify and mitigate Quality related Risks. In addition, you will collaborate with cross-functional teams such as procurement and supplier management to establish and maintain robust supplier quality management processes and conduct supplier audits and evaluations. You will partner with teams to integrate quality into product development and operational processes.
To thrive in this role, you are an effective and flexible leader with strong project management skills, proven experience supporting and driving organizational change, and the ability to foster a culture of quality excellence, accountability, and continuous learning in junior team members. You promote and demonstrate safe behaviors, lead by example and engage teams in Safety, Health, and Environment activities. You have demonstrable knowledge relative to the agriculture industry (ISO, GMP, OMRI) to ensure compliance and maintain Kula Bio's space as a leader in the Biotech and Fermentation market. You align with our mission and vision to make a difference by reducing climate impacts.
Requirements
Professional Requirements:
Proven experience (5+ years) in supervisory quality management roles within manufacturing of biologicals , preferably in Ag-Biotech and/or fermentation industry
Ph.D. in Analytical chemistry or biochemistry with at least three (3) years of experience beyond the Ph.D.
Certification in Quality Management (e.g., ASQ Certified Quality Manager, Six Sigma Black Belt)
Related Qualifications:
Strong analytical experience in advanced organic and inorganic characterization of fermentation products
Experience with analyzing plant and/or soil-derived molecules is a plus
Prior hands-on experience in assay development and qualification/validation
In-depth knowledge of quality management principles, standards, and methodologies (e.g., ISO 9001)
Analytical mindset with the ability to drive data-driven decision-making and problem-solving
Experience with quality management software tools (e.g., QMS, EQMS) and statistical analysis techniques
Kula Bio is an equal employment opportunity employer and is committed to a proactive program of diversity development. Kula Bio will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.
Salary Description
$130,000 - $150,000/Year
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Email Alert for Associate Director, Quality jobs in Natick, MA, United States
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